3-A Sanitary and Hygienic
Darcoid works with Rubber Fab which has a large inventory of O-Rings for Cherry Burrell®, Evergreen®, International Paper®, Pure Pak®, Liqui-Box®, Nimco®, Gram®, Sweetheart®, Portion Pak®, Anderson® and other sanitary fillers. Standard materials available include Buna, EPDM, FKM and Silicone.The gasket materials considered are Tuf-Steel® (PTFE/Stainless Steel),Tuf-Flex®, PTFE, Silicone (Platinum), FKM Fluoroelastomer, EPDM and Buna-N.
Most decisions driving seal type selection are based on chemistry, temperature, exposure limits, USP, FDA qualifications, and curing methods.
In determining correct sanitary gasket materials, the following criteria are used:
- U.S. Pharmacopeia Class VI Certification
- Cytotoxicity Criteria
- CFR Title 21 Section 177.1550
- CFR Title 21 Section 177.2600
- Traceability: Lot and Batch Certification: Lot and Batch
- ASME-BPE Standards
- USDA Standards
- 3-A Sanitary Standards
- Current Good Manufacturing Practices (CGMP)
- Manufacturer data and specifications
- Consultation with various pharmaceutical users